To assess the effects of treatment with XOMA 052 on beta-cell function and insulin production in subjects with well-controlled Type 1 diabetes. The safety, tolerability, and pharmacokinetics (PK) of XOMA 052 will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
22
0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
University Hospital Basel
Basel, Basel, Switzerland
C-peptide level
Time frame: incremental AUC over 120 minutes during the MMTT at Day 112 compared to baseline (Day 0 pre-dose
Change in insulin requirements
Time frame: 3-day average daily insulin dose at baseline (Day -3 through Day -1) compared to Day 112 (Day 109 through Day 111)
HbA1c levels
Time frame: from baseline (Day 0 pre-dose) at Day 112
fasting glucose
Time frame: from baseline (Day 0 pre-dose) at Day 112
fasting glucagon
Time frame: from baseline (Day 0 pre-dose) at Day 112
cortisol
Time frame: from baseline (Day 0 pre-dose) at Day 112
markers of systemic inflammation (Interleukin-6, Interleukin-8, Tumor Necrosis Factor α, hs-CRP)
Time frame: from baseline (Day 0 pre-dose) at Day 112
adipokines
Time frame: from baseline (Day 0 pre-dose) at Day 112
meal-stimulated Glucagon like peptide-1
Time frame: AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose)
meal-stimulated gastric inhibitory polypeptide
Time frame: AUC over 120 minutes at Day 112 compared to baseline (Day 0 pre-dose)
lipids profile
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Time frame: from baseline (Day 0 pre-dose) at Day 112
Change in fatigue according to the Fatigue Scale for Motor and Cognitive Functions (FSMC) questionnaire
Time frame: from baseline at Day 112
Anti XOMA 052 Antibodies
Time frame: from baseline (Day 0 pre-dose) at Day 112
Number of Adverse Events
Time frame: from baseline (Day 0 pre-dose) at Day 364